Recruitment

Recruitment Status
Completed

Inclusion Criterias

The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
The patients must provide written informed consents
The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
...
The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
The patients must provide written informed consents
The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
The patient's life expectancy is ≥3 months
The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert
The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
The patients must be willing and able to complete the biweekly visits for the first 3 months;

Exclusion Criterias

The patients participated in other clinical trials
The patients received sorafenib therapy prior to enrollment
The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
...
The patients participated in other clinical trials
The patients received sorafenib therapy prior to enrollment
The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
The patient's sorafenib dosage exceeds 400mg, twice daily

Summary

Conditions
Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no random...

Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no randomized, controlled trials to date have evaluated treatments to prevent/palliate sorafenib-associated HFSR. We therefore tested the prophylactic effects of a urea-based cream on the incidence of HFSR associated with sorafenib treatment of patients with advanced HCC.

Inclusion Criterias

The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
The patients must provide written informed consents
The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
...
The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
The patients must provide written informed consents
The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
The patient's life expectancy is ≥3 months
The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert
The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
The patients must be willing and able to complete the biweekly visits for the first 3 months;

Exclusion Criterias

The patients participated in other clinical trials
The patients received sorafenib therapy prior to enrollment
The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
...
The patients participated in other clinical trials
The patients received sorafenib therapy prior to enrollment
The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
The patient's sorafenib dosage exceeds 400mg, twice daily

Locations

Guangzhou, Guangdong, 510630
Shanghai, Shanghai, 200032
Nanjing, Jiangsu, 210002
Tianjin, Tianjin, 300060
Beijing, Beijing, 100039
...
Guangzhou, Guangdong, 510630
Shanghai, Shanghai, 200032
Nanjing, Jiangsu, 210002
Tianjin, Tianjin, 300060
Beijing, Beijing, 100039
Guangzhou, Guangdong, 510080
Haerbin, Heilongjiang, 150081
Fuzhou, Fujian, 350001
Shanghai, Shanghai, 200438
Changchun, Jilin, 130012
Beijing, Beijing, 100039

Tracking Information

NCT #
NCT01934829
Collaborators
Not Provided
Investigators
  • Principal Investigator: Sheng-Long Ye, PHD Zhongshan Hospital, Fudan University, Shanghai, China
  • Sheng-Long Ye, PHD Zhongshan Hospital, Fudan University, Shanghai, China